The major hypothesis to be tested is that the treatment of intraabdominal infections that have been adequately treated operatively or by percutaneous techniques with three to five days of antibiotics will result in outcomes equivalent to the current standard where treatment is carried out until the patient has returned to normal (normal white blood cell count, temperature, and intestinal function), and that patients treated for three to five days will receive fewer days of antibiotics than the control group that has traditionally received seven to 14 days of treatment.

antibiotics received for up to two days following normalization of white blood cell count, temperature, and gastrointestinal function

Other: duration of antibiotics

active comparator antibiotics given until 2 days after resolution of fever, elevated white blood cell count, and gastrointestinal dysfunction.

Other Name: long course

Experimental: 2

4 +/- 1 days of antibiotics

Other: duration of antibiotics

4 +/- 1 days of antibiotics

Other Name: short course

Detailed Description:

Overall, this is a prospective, randomized, single-blinded (analysis), fifteen-center study using intent to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive antibiotics for 3 to 5 days (4 ± 1 days) after the initial surgical or percutaneous intervention or antibiotics until two calendar days after the patient's white blood cell count, systemic temperature, and gastrointestinal function have normalized (maximum of 10 days). The primary endpoint is the composite rate of in-hospital death and/or recurrence of intraabdominal infection and/or occurrence of surgical site (wound) infection. Secondary endpoints include the occurrence of any infection at any site and infection with antibiotic-resistant pathogens. Patient data through the thirty days following the initial intervention or until hospital discharge (whichever is longer) will be tracked

Eligibility

Ages Eligible for Study:

16 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

age ≥ 16 at some sites,(≥ 18 at UVA)

ability to obtain informed consent from the subject or surrogate

Presence of an intraabdominal infection requiring any duration of hospitalization and managed with open, laparoscopic, or percutaneous intervention.

Adequate source control in the opinion of the local investigator and PI. Source control is defined as any procedure that stops the ongoing contamination of the peritoneal cavity and removes the majority of the contaminated intraperitoneal contents to the extent that no further acute interventions are felt to be necessary.

Exclusion Criteria:

age < 16 years at some sites(< 18 at UVA)

Inability to obtain consent from the patient, parents, or surrogate

Lack of adequate source control in the opinion of the local investigator or overall PI ( Robert Sawyer)

High likelihood of death within 72 hours of initial intervention in the opinion of the local investigator or principal investigator

Lack of any clinical improvement within 72 hours of initial intervention in the opinion of the local investigator or principal investigator.

Planned relaparotomy

Perforated gastric ulcer or duodenal ulcer treated within 24hours of the onset of symptoms

Traumatic injury to the bowel (including iatrogenic or intra-operative) treated within 12 hours of injury

Non-perforated, non-gangrenous appendicitis or cholecystitis

Gangrenous appendicitis or peritonitis without confirmatory cultures or with cultures without bacterial or fungal growth

Ischemic or necrotic intestine without perforation and without positive bacterial or fungal cultures

Primary skin closure of an open surgical incision in the presence of diffuse, non-localized peritonitis. Laparoscopic port sites ≥ 2cm may be closed

Pregnancy

Prior enrollment in this study

Enrollment in another therapeutic trial

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657566